Management of Tuberculosis Training for Health Facility Staff. F: Manage Drugs and Supplies for TB. WORLD HEALTH ORGANIZATION Geneva

Transcription

1 Management of Tuberculosis Training for Health Facility Staff F: Manage Drugs and Supplies for TB WORLD HEALTH ORGANIZATION Geneva

2 WHO/CDS/TB/ f Management of Tuberculosis Training for Health Facility Staff F MANAGE DRUGS AND SUPPLIES FOR TB World Health Organization Geneva 2003

3 Acknowledgements Management of Tuberculosis Training for Health Facility Staff This set of training modules has been prepared by the Stop TB Department, World Health Organization, Geneva, through a contract with ACT International, Atlanta, Georgia USA. The project was coordinated by Karin Bergstrom. Fabio Luelmo was the main technical adviser. The American Lung Association (ALA), the American Thoracic Society (ATS), the Centers for Disease Control and Prevention (CDC), Atlanta and the Royal Netherlands Tuberculosis Association (KNCV) have all contributed to the development of the modules through the Task Force Training (TFT) of the Tuberculosis Coalition for Technical Assistance (TBCTA). The modules were field-tested in Malawi through the support of the National Tuberculosis Control Programme of Malawi. This publication was partially funded by the Office of Health, Infectious Diseases and Nutrition, Bureau for Global Health, United States Agency for International Development, through the Tuberculosis Coalition for Technical Assistance, a cooperative agreement to accelerate the implementation and expansion of the DOTS strategy in developing countries.

4 Manage Drugs and Supplies for TB Contents Page Introduction...1 Objectives of this module Stock sufficient drugs for treatment of all TB cases About presentations and packaging of anti-tb drugs Estimate the expected number of new cases in each treatment category and the drugs needed next quarter Check drugs received Periodically, check drug stocks Plan for other needed supplies Estimate required quantity of sputum containers Estimate required needles and syringes for streptomycin injections Estimate TB forms and registers needed Periodically, check stocks of supplies Use good storage and management procedures for anti-tb drugs and supplies Keep drugs safe Keep the storeroom in good condition Organize drugs and supplies Recognize and correct storage problems...11 Summary of important points...13 Self-assessment questions...15 Answers to self-assessment questions...16 Exercise A...18 Annexes...21 A: How to read the drug code for TB treatment regimens...22 B: Guidelines for assembling drug boxes for TB patients...23 C: Examples of recommended TB treatment regimens...30

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6 Manage Drugs and Supplies for TB Introduction Essential drugs and other supplies for detecting and treating TB in a health facility include: drugs for TB treatment (sufficient quantities of oral drugs for complete regimens, plus streptomycin and additional tablets) treatment-related supplies, such as syringes, needles and sterile water for injection sputum containers TB forms and registers. The health facility must keep sufficient quantities in stock and store them carefully, so that they will be available and effective when they are needed. The national TB programme provides complete regimens of anti-tb drugs free of charge for all TB patients. Patients do not have to be concerned with the cost of their drugs, and cost is eliminated as a barrier to taking the correct drugs for the recommended duration. Different presentations and methods of packaging of anti-tb drugs can be provided by manufacturers today. WHO recommends the use of fixed-dose combinations in blister packs or strips to facilitate correct drug intake. Drug boxes that contain a full drug regimen for a patient are also recommended to ensure correct drug treatment and avoid interruptions of supply during treatment. Managing drugs and supplies involves ensuring that sufficient quantities are available and maintaining good storage conditions for them. Generally, quantities of drugs and supplies to order are calculated as follows: Estimated drug requirements + reserve stock current stock = amount to order Whether your health facility places orders for supplies or the district determines the amounts to send, you should still be aware of quantities that should be in stock. Then if stocks are low, you can react in time to request resupply. Good storage and management procedures will keep the drugs and supplies safe from theft, misuse, or spoiling. Objectives of this module Participants will learn: Refer to section: How to ensure sufficient stock of drugs for TB patients 1 How to plan for other supplies 2 Good drug management procedures for safe keeping the supply of anti-tb drugs 3 1

7 1. Stock sufficient drugs for treatment of all TB cases 1.1 About presentations and packaging of anti-tb drugs The drugs currently used in standard regimens for treatment of tuberculosis (with their standard abbreviations) are: isoniazid (H) rifampicin (R) pyrazinamide (Z) ethambutol (E) streptomycin (S) These drugs are manufactured in different presentations. You will use the presentations that are provided to your health facility for treatment of TB patients, but you should be aware of other possible presentations. Each of these drugs has been manufactured in tablet form. If a country uses separate tablets of each of these drugs, a TB patient on the regimen 2HRZE would receive each day a specific number of isoniazid tablets, rifampicin tablets, pyrazinamide tablets, and ethambutol tablets. 1 Most anti-tb drugs are now manufactured in fixed-dose combinations (FDCs) instead of only separate tablets. Fixed-dose combinations are drugs combined in tablet or capsule form, in specific dosages, to facilitate correct drug intake. The following FDCs are becoming widely available: 2 isoniazid rifampicin pyrazinamide ethambutol (HRZE) isoniazid rifampicin pyrazinamide (HRZ) isoniazid rifampicin pyrazinamide (HRZ) 3 isoniazid rifampicin (HR) isoniazid rifampicin (HR) 3 isoniazid ethambutol (HE) FDCs have many advantages. They help to reduce mistakes by the health worker or the patient, so that the correct drugs in the correct doses are taken by the patient each day. They reduce the number of tablets to take from 9 12 down to 3 4. They also increase compliance. FDCs are often cheaper than separate drugs. Use of FDCs is essential for self-administered treatment. Fixed-dose combinations are strongly recommended by WHO, and more and more countries are choosing to provide FDCs for treatment of TB patients. If your country is not yet using FDCs, or is using only one FDC such as (HR), you can look forward to using more FDCs for TB patients in the future. 1 See Annex A for a review of how to read the drug code for TB treatment regimens. 2 (HRZE), (HRZ), (HR) and (HE) are made in dosages for daily administration. (HR) 3 and (HRZ) 3 contain the appropriate dosages of each drug for 3 times per week administration. 2

8 Another development that is important for health workers is in the packaging of anti-tb drugs. In the past, all anti-tb drugs were provided as loose pills in bottles. Health workers had to package these for patients: Manufacturers now package anti-tb drugs in some additional ways, including: Strips Blister packs of several tablets for a daily dose on one card, or a week s tablets on one card Blister packs of 28 FDC tablets on a card, such as 28 (HRZE) or 28 (HR) tablets WHO strongly recommends blister packs or strips, preferably of FDCs. In addition, some manufacturers package anti-tb drugs in boxes or bags containing a full treatment regimen for one patient. Each box or bag contains the correct number of prepackaged daily blister packs or envelopes for the regimen. These drug boxes are an important tool for ensuring correct drug treatment and avoiding interruptions of supply during treatment. Drug boxes are strongly recommended by WHO. 3

9 When a TB patient is identified, the health worker determines the patient s category of treatment and specifies the regimen needed and the dosages (based on the patient s body weight). A drug box containing the appropriate regimen is labelled with the patient s name and kept for him or her only. In this way, the health facility is certain to be able to provide the full course of drug treatment needed by the patient. The health worker and the patient can be confident that the patient will never come for treatment to find that the health facility has run out of drugs. Daily drug administration is simplified for the staff because the drugs are labelled for the patient and are pre-packaged in daily doses. Determining when the patient has completed the treatment is also easy, because the patient continues until all the drugs in the box have been taken as recommended. If your health facility does not receive anti-tb drugs pre-packaged as a complete regimen for one patient, WHO recommends assembling drug boxes. Health workers may assemble boxes for different treatment categories and body weight ranges ahead of time, or they may partially assemble boxes that will be completed when a TB patient is identified. As soon as a diagnosis of TB is made, a drug box is taken from the shelves. If a box is not already assembled for the category and weight of patient, it is quickly assembled. For example, an additional number of tablets may be added to a box to increase the daily dose for a heavier patient. The box is labelled with the patient s name and kept for that patient. Using the 4-drug FDC (HRZE) greatly simplifies assembly of drug boxes. For example, for Category I treatment, a patient of average weight needs 3 (HRZE) tablets per day in the initial phase for 2 months. If (HRZE) tablets are provided in blister packs of 28 tablets, the patient s treatment box would contain 3 of these blister packs per month of treatment, or 6 blister packs for the initial phase. Making drug boxes with blisters of FDCs is far simpler and more likely to be done correctly than if loose drug tablets (not FDCs) are used. If loose tablets are used, a health worker must assemble 56 envelopes containing 9 12 tablets each. 4

10 The Category II regimen includes streptomycin, which is not placed in the drug box. However, a supply of streptomycin (56 doses of streptomycin, 5 ml sterile water per gram of streptomycin, sterile needles and syringes) should be available in reserve for each patient on Category II treatment. 1.2 Estimate the expected number of new cases in each treatment category and the drugs needed next quarter Be sure that enough drugs are in stock for all TB cases expected to start treatment during the next quarter (all categories of treatment). It is assumed that the number of new patients in each treatment category next quarter will be the same, or approximately the same, as it was in the previous quarter. At the beginning of each quarter, the District TB Coordinator will determine these numbers from records of current cases and will order drugs to be sent to your health facility to meet the expected need. Though you may not be required to place drug orders each quarter, you should be aware of the usual quantities used, so that you will know whether the supplies you receive are far too much or too little. The expected new cases in each category next quarter, multiplied by 2, is the number of drug regimens that should be available when your health facility s drug storeroom is fully stocked. (Depending on the practice of your national TB programme, these regimens may be packaged in patient drug boxes or may be the equivalent in supplies of different anti-tb drugs.) The reserve stock allows for possible increases in the number of cases and extra supplies in case of delay in drug delivery. Some additional tablets will be needed for patients who need one extra month of initial-phase treatment (about 10% of patients in treatment Categories I and II) and for heavier adults who need larger than standard doses. Some loose tablets will be needed for children who need less than standard doses. The expected new cases in each category next quarter, multiplied by 2, is the number of regimens that should be available when your health facility s drug storeroom is fully stocked. 1.3 Check drugs received When drugs are received from the district or the Essential Drugs Programme, check that the correct drugs were received in the correct quantities. If not, request the missing drugs and return any extra or expired drugs that were sent in error. Depending on the system used, this can be a fairly simple step, or it may be quite complicated. If your health facility receives boxes or bags containing full treatment regimens for a given patient, the task is just to count the number of boxes of each regimen received and compare with the amount needed. 5

11 However, some health facilities receive bulk quantities of all the different drugs that must be counted out and assembled in boxes for each regimen. In this case, there is greater possibility for error in supplies; for example, the shipment could include too many (HR) tablets (isoniazid rifampicin combination tablets) and no E (ethambutol tablets). When a drug shipment is received: Receive and sort through the drug shipment: Check expiry dates Identify number of complete regimens received (drug boxes or the equivalent drugs for treatment) for each category of treatment Identify additional tablets received and their strengths Check the quantities of each received and compare with amount needed. Note discrepancies (e.g. incorrect number of complete drug regimens for a category, incorrect tablet or strength of tablet, insufficient quantity of a particular tablet, expired drugs). Request missing drugs, return extra drugs, return or destroy expired drugs. Place the drugs in stock, recording them on the stock card for the item and placing them on the shelves behind older stock. 1.4 Periodically, check drug stocks With experience, you will be aware of the number of TB cases entering treatment each quarter and the quantities of drugs needed to treat them. If you think that the health facility s stocks do not contain sufficient quantities for the quarter, a special order may be needed. Take action or inform the person responsible for drug supplies. A periodic check of drug supplies will also be performed by staff of the Essential Drugs Programme. STOP Now read Annex B If your health facility will need to assemble drug boxes for TB patients from supplies of anti-tb drugs in blister packs, strips, loose tablets or some combination of these, turn to page 20 and read Annex B, Guidelines for assembling drug boxes for TB patients. When you have finished reading the annex, go back to page 7 and continue reading. If your health facility will not assemble drug boxes, you do not need to read Annex B. Turn this page and continue reading in the module. 6

12 2. Plan for other needed supplies Make sure that your health facility maintains an adequate supply of sputum containers, disposable needles and syringes, and sterile water for injections. If adequate disposable needles and syringes are not available, the health facility must have reusable needles and syringes and a sterilizer in good working condition. Estimate the quantities needed of each of these supplies, and periodically check the quantities in the storeroom. If supplies will not meet the needs, request more according to usual procedures. 2.1 Estimate required quantity of sputum containers A large number of sputum containers are needed to identify and investigate TB suspects and to follow up patients. A shortage of sputum containers is a serious problem. Estimate quarterly needs for sputum containers based on the expected number of sputum examinations to be done for diagnosis plus the expected number to be done for follow-up. Base estimates on the number of new cases treated last quarter. When estimating and ordering sputum containers, it is recommended to round numbers up. Example methodology for calculating the number of sputum containers needed The number of sputum containers needed for diagnosis may be calculated as follows: number of new pulmonary sputum smear-positive cases last quarter multiplied by 10 (because on average, 10 TB suspects have been investigated for each new pulmonary sputum smear-positive case detected) 3 multiplied by 3 (because 3 sputum samples are needed from each TB suspect). 22 new smear-positive cases x TB suspects x sputum containers for diagnosis 3 This number may vary by country or region. It depends on case detection activity and the prevalence of TB in the community. 7

13 The number of sputum containers needed for follow-up of treatment is calculated as follows: number of new sputum smear-positive cases last quarter multiplied by 6 (3 follow-up examinations of 2 sputum samples each time). number of re-treatment cases multiplied by 6 (3 follow-up examinations of 2 sputum samples each time). 22 new smear-positive cases x containers 5 re-treatment cases x 6 30 containers 11 smear-negative cases x 2 22 containers = 184 containers number of sputum smear-negative cases multiplied by 2 (one follow-up examination of 2 sputum samples). The total number of sputum containers to order 4 is calculated as follows: number needed for diagnosis plus number needed for follow-up examinations plus 10% for additional investigations plus 20% for reserve stock minus the number of sputum containers in stock at the end of last quarter. 660 for diagnosis for follow-up for additional for reserve stock 1114 TOTAL needed in stock 864 to order 2.2 Estimate required needles and syringes for streptomycin injections Streptomycin injections must be given with sterile needles and syringes. Avoid transmission of bloodborne diseases (especially HIV infection). In areas with high prevalence of HIV infection, disposable syringes and needles should be used. If disposables are to be used, the number of syringes and needles needed is the same as the number of doses of streptomycin. Example methodology: number of patients on Category II treatment whose regimens included streptomycin last quarter multiplied by 56 doses per patient (28 doses per month) multiplied by 2 for reserve stock minus the number of syringes in stock at the end of last quarter 8 patients on streptomycin x 56 doses per patient 448 doses (and syringes) needed x 2 for reserve stock 896 syringes needed when fully stocked - 80 in stock 816 to order 4 A simplified method to calculate the number of sputum containers to order is as follows: Multiply by 50 the number of new pulmonary smear-positive cases last quarter. Then subtract the number of containers in stock at the end of last quarter. 8

14 If reusable needles and syringes will be used, follow normal procedures for estimating need and ordering them. You may need to inform the person responsible for supplies about the estimated number of TB patients who will require streptomycin injections. Recommended procedures for sterilization of needles and syringes must be strictly followed. Make sure that the sterilizer is in good working condition. Also plan for there to be a sufficient number of vials of sterile water in stock, reserved for TB cases. (For each gram of streptomycin, 5 ml of sterile water is also required.) 2.3 Estimate TB forms and registers needed The District TB Coordinator will make sure that sufficient forms are available. Generally, forms will be provided once a year to cover the needs for the entire year. Estimates are based on the number expected to be used in the year plus 20% to allow for increases in detection of new TB cases and losses through misuse or damage. TB Treatment Cards Some patients will have only one TB Treatment Card, while patients who have a community TB treatment supporter will have two cards. Thus, on average, 1.5 TB Treatment Cards are needed for each expected patient (all categories) plus 20% for reserve. Referral/Transfer forms Referral/Transfer forms are needed for about 3 in 10 TB patients. Calculate 30% of the expected patients, and then add 20% for reserve. 325 expected patients/year x forms + 20 for reserve 118 forms needed Request for Sputum Examination forms Estimate about 15 Request for Sputum Examination forms per new sputum smearpositive case. 5 Register of TB Suspects Generally, one Register of TB Suspects is sufficient for a small or medium-sized health facility for a year (that is, a register book containing 60 pages with 20 lines per page). 5 The factor of 15 is based on the average of 10 diagnostic sputum examinations to detect 1 sputum smearpositive TB case, plus 3 follow-up sputum examinations per smear-positive case, plus 2 for follow-up of smearnegative cases and reserve. The factor may be adjusted depending on case detection activity and the prevalence in the community. 9

15 2.4 Periodically, check stocks of supplies Periodically, check stocks of needles, syringes, sputum containers, forms and registers. If the facility uses reusable needles and syringes, also check that the sterilizer is in good working condition. If supplies of any of these items will not meet the expected needs for the quarter, alert the person responsible that certain supplies are low, or request more according to usual procedures. 3. Use good storage and management procedures for anti-tb drugs and supplies Health facility drugs and supplies are kept in the health facility s drug storeroom, which should be well kept and managed by a designated responsible staff member. Good storage and management procedures are important for anti-tb drugs (and all drugs) and supplies kept in the storeroom or cabinet. If you handle drugs and supplies for TB, you should do your part to ensure that good storage procedures are followed. If there are problems that you are not able to correct, you must talk to the person responsible or the medical officer. 3.1 Keep drugs safe Stocks of anti-tb drugs are kept safe in the main storeroom which should be locked when not in use. Access to the main drug storeroom should be limited to one or two people who are responsible for management of the main storeroom. Keep drugs for current TB patients available for when the patients come for directly observed treatment. This could be in a cabinet or on a shelf in the area where patients are seen. These drug supplies should be available (not be locked up) so that staff can get to them even if the normal treatment provider is not present. 3.2 Keep the storeroom in good condition The temperature, light and humidity in the main storeroom should be kept moderate. Though anti-tb drugs are very stable, a drug storeroom should not have excessive heat, light or humidity, as these can cause some drugs to spoil. For instance, some tablets, such as ethambutol, absorb humidity from the air and deteriorate. Storage conditions can be improved by some simple measures. Collaborate with other staff if needed to improve storage conditions. Temperature can be controlled by using fans, air vents or windows to increase ventilation, and by using insulating materials for the roof and ceiling. Direct light can be prevented from entering the room by hanging curtains or painting the window glass. Humidity can be controlled by increasing ventilation, creating drainage areas, and repairing any roof leaks quickly. No one should eat, drink or smoke in the storeroom. Do not keep food or drink in the storeroom. This will help to keep the storeroom clean and free of pests. 10

16 3.3 Organize drugs and supplies Stocks of anti-tb drugs in the storeroom (in individual patient drug boxes or stocked by type of drug) should be placed on shelves by expiry date: the drugs that expire soonest should be in front and those that expire later should be behind. When taking drugs off the shelf, use those in front first. These procedures follow the FIFO rule (meaning First In, First Out) so that the oldest drugs are used first. Return expired drugs to the district office or destroy them. 3.4 Recognize and correct storage problems Periodically check the condition of the anti-tb drugs (those kept in the storeroom and those kept handy for current patients) to identify any problems. When a problem is identified, correct it without delay. For example, if a drug cabinet is in direct sunlight, move it or block the light with curtains. If drugs are stored on the floor, move them onto shelves. If some expired drugs are found on the shelves, dispose of them and then check the expiry dates of the other drugs. STOP Now do Exercise A Group practical exercise When you have reached this point in the module, you are ready for Exercise A. Turn to page 22 and read the instructions. When everyone is ready, the facilitator will conduct the exercise. 11

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18 Summary of important points Essential drugs and other supplies for detecting and treating TB include: Drugs for TB treatment (sufficient oral drugs for complete regimens, streptomycin, and additional tablets) Treatment-related supplies (syringes, needles, and sterile water for injection) Sputum containers TB forms and registers. Fixed-dose combinations (FDCs) are drugs combined in tablet or capsule form, in specific dosages, to facilitate correct drug intake. FDCs, preferably in blister packs or strips, reduce mistakes by the health worker, community treatment supporter or patient. Be sure that enough drugs are in stock for all TB cases (all treatment categories) expected to start treatment during the next quarter. The number of expected cases, multiplied by 2, is the number of drug regimens that should be available when your storeroom is fully stocked. Remember that the Category II regimen also requires that a sufficient supply of streptomycin, sterile water, sterile needles and syringes be held in reserve for TB patients. Drug boxes that contain all the drugs for a full treatment regimen for one patient are an important tool for ensuring correct drug treatment and adherence. If your health facility does not receive boxes of drugs packaged in complete regimens, you will have to assemble drug boxes. Drug boxes should be ready to use or be quickly assembled when new patients are diagnosed. When you gather drugs for making drug boxes, check the expiry dates. Use older stock first. Do not use any drugs that have expired or will expire during the treatment period. A drug box should contain the entire course of treatment, with each dose in a blister pack or small envelope. Use a Worksheet for drug box assembly to plan, for the two phases, the drugs needed, number of tablets for each dose, and the number of doses needed. When a drug box is assembled, clearly label the box with the treatment category, drug code for the treatment regimen, patient s weight range, and expiry dates of the drugs. A large number of sputum containers are needed. Calculate the total number of sputum containers to order for the quarter as follows: number needed for diagnosis plus number needed for follow-up examinations plus 10% for additional investigations plus 20% for reserve stock minus the number of sputum containers in stock at the end of last quarter. TB forms and registers needed include: TB Treatment Cards (average 1.5 per TB patient) Tuberculosis Referral/Transfer Form Request for Sputum Examination forms (about 15 per new smear-positive case) Register of TB Suspects 13

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20 Self-assessment questions Answer the self-assessment questions below to check what you have learned. Then compare your answers to those on the next page. 1. Whether they are delivered to the health facility or assembled at the health facility,, which contain all the drugs for a full for one patient, are an important tool to ensure correct drug treatment and compliance. 2. Estimates of anti-tb drugs needed for different categories of treatment next quarter are based on the expected number of new TB patients. It is assumed that the number of new patients in each treatment category next quarter will be. 3. List at least three things to check when you receive a shipment of drugs: 4. A Category I regimen is 2(HRZE) / 4(HR) 3. How many total doses are required for the initial phase? How many for the continuation phase? (If you do not know the answer to Question 4, refer to Annex C.) 5. List critical supplies for TB management (other than drugs) to stock at a health facility. For sputum examination: (list 1 item) For streptomycin injections: (list 3 items) Forms and registers: (list 4 items) 6. The number of sputum containers needed for the next quarter can be calculated based on the number needed for, plus the number needed for. This number is then increased by a percentage for additional investigations and an additional percentage for reserve stock. Now compare your answers with those on the next page. 15

21 Answers to Self-Assessment Questions If you had difficulty answering any question, turn back and study the section indicated. If you do not understand something, discuss it with a facilitator. 1. Whether they are delivered to the health facility or assembled at the health facility, drug boxes, which contain all the drugs for a full treatment regimen for one patient, are an important tool to ensure correct drug treatment and compliance. (See Introduction.) 2. It is assumed that the number of new patients in each treatment category next quarter will be the same, or approximately the same, as in the previous quarter. (See 1.2) 3. Check: expiry dates (drugs not expired or about to expire) correct drugs received correct strength of drugs received quantities received are amounts needed (See 1.3) 4. The initial phase of this regimen is 2 months of daily treatment, which is 56 doses (28 doses per month x 2 months) The continuation phase is 4 months of 3 times per week treatment, which is 48 doses (12 doses per month x 4 months). (See Annex C) 5. Critical supplies for TB management to stock at a health facility include: For sputum examination: sputum containers For streptomycin injections: Sterile needles, sterile syringes, sterile water for injection. If your health facility uses reusable needles and syringes, you may have listed a sterilizer in good working condition. Forms and registers: TB Treatment Cards, Request for Sputum Examination forms, Tuberculosis Referral/Transfer forms, Register of TB Suspects (See section 2) 6. The number of sputum containers needed for the next quarter can be calculated based on the number needed for diagnosis, plus the number needed for follow-up examinations. This number is then increased by a percentage for additional investigations and an additional percentage for reserve stock. (See 2.1) The End Congratulations on finishing this module! 16

22 Exercises for Module F: Manage Drugs and Supplies for TB 17

23 Exercise A Group Practical Exercise Examining a drug box for a TB patient For this exercise, your facilitator will distribute several drug boxes for TB among the group. You will examine a drug box to see the different drugs, how they are packaged and how they are labelled. Then there will be a group discussion of how drug boxes are prepared and stored at your health facility. Part 1 Examine a drug box Examine the box that you are given and its contents. Determine the following and write in the blanks: Category of treatment: The patient s weight (range) for which this box is appropriate: Size, shape and colour of different anti-tb drugs: Are drugs separate or combination drugs (FDCs)? How are each day s tablets packaged (blister packs, envelopes)? How are they labelled as to regimen and phase? Number of doses included for the initial phase: Number of doses included for the continuation phase: 18

24 Part 2 Discussion Write your answers to the questions below in preparation for the discussion. a) Assembly: Are drug boxes assembled or modified at your health facility? If not, skip to b) below. If so, be ready to describe: Formulation and packaging of the drugs as they are provided to the health facility How staff plan what goes into each drug box How and when assembly of boxes is done b) Storage and use: Where are drug boxes for TB stored at your health facility? Are storage conditions for drug boxes satisfactory? Why or why not? How do you identify the correct drug box (correct regimen) for a new patient among all those on the shelves? How do you label a new drug box when it is assigned to a new TB patient? 19

25 Where are drug boxes kept for patients who are currently being treated? Are those storage conditions satisfactory? Why or why not? Tell your facilitator when you are ready for the discussion. When the group has finished the discussion, GO BACK to page 13 and read and work to the end of the module (page 16). 20

26 Annexes A. How to read the drug code for TB treatment regimens B. Guidelines for assembling drug boxes for TB patients C. Dosages for recommended treatment regimens

27 Annex A How to read the drug code for TB treatment regimens TB treatment regimens are described using a standard code according to which each anti-tb drug has an abbreviation. Those abbreviations are: Isoniazid (H) Rifampicin (R) Pyrazinamide (Z) Ethambutol (E) Streptomycin (S) Example one: A common regimen is written: The code shows the 2 phases of the regimen, separated by a slash. The letters correspond to the drugs to take during the phase. This continuation phase is of 4 months duration. The number before the letters is the duration of the phase in months. This initial phase is 2 months. 2(HRZE) / 4(HR) 3 A subscript number after a letter is the number of doses of that drug per week. Frequency of treatment with the combination HR tablet should be 3 times per week. When 2 or more drugs (letters) appear in parentheses, this indicates a combination tablet of those drugs. If there is no subscript number after a letter, frequency of treatment with that drug is daily. These initial-phase drugs should be taken daily. The above regimen uses 2 fixed-dose combination tablets (also called FDCs). In the initial phase of 2 months, each day the TB patient would take a certain number (depending on the patient s weight) of the combination tablet of isoniazid, rifampicin, pyrazinamide and ethambutol. In the continuation phase, the TB patient would take a certain number of FDCs of isoniazid and rifampicin (HR) 3 times per week for 4 months. Example two: 2(HRZE)S/1(HRZE) /5(HR) 3E 3 The initial phase is 3 months but has two parts. For 2 months, drug treatment includes an FDC with isoniazid, rifampicin, pyrazinamide and ethambutol (HRZE) administered daily and also a daily injection of streptomycin (S). In the third month, drug treatment is with the combination tablet (HRZE); the streptomycin is not given. The continuation phase is 5 months. Drug treatment is with the FDC tablet (HR) given 3 times per week (subscript number 3 after the letters) and ethambutol (E), also given 3 times per week. 22

28 Annex B Guidelines for assembling drug boxes for TB patients If your health facility does not receive boxes of drugs packaged in complete regimens, you will have to assemble drug boxes. Exactly how to do this will depend on the national TB programme s recommendations for each regimen, the presentations and packaging of the anti-tb drugs provided to your health facility, and the number of different weight categories. For example, if one day s dose for the most common weight category is packaged in a blister pack, such as 3 (HRZE) tablets on one card, you will need only to count 56 of these cards for the initial phase and put them into the box. On the other hand, if the health facility is provided (HR) tablets, Z tablets and E tablets, it will take more time and care to prepare a box. You would have to count the number of each tablet needed each day, place the tablets into a small envelope, label it, and repeat this to make 56 envelopes for the initial phase. Staff in some health facilities, particularly those that treat only a few TB patients, wait to assemble a drug box until a new TB patient is ready to begin treatment. The health worker then prepares the regimen for the appropriate treatment category and body weight. If this is the procedure in your health facility, however, you should complete as much assembly as possible ahead of time. Some health facilities find it more efficient to preassemble several drug boxes for the most common categories and weight ranges. If you choose to do this, take care not to assemble more boxes than will be used in the short term, so that drugs do not expire before they are used and quantities of drugs are not reserved for categories or weight ranges that are not needed. Some national TB programmes provide drug boxes with the correct daily dosages of anti-tb drugs for a patient of average weight (38 54 kg), for example, for Category I, 3 (HRZE) tablets per day. Health staff must modify the boxes as needed for patients who weigh outside the average range. If the patient is lighter than average (30 37 kg), one set of tablets is removed from the box, leaving 2 tablets per day. If the patient is heavier (55 69 kg), one set of tablets is added, making 4 tablets per day. Whatever the formulation and packaging of the anti-tb drugs provided to your health facility, work out a procedure for preparing drug boxes so that most of the assembly can be done when the health facility is not busy. A drug box should be ready or very quickly prepared for use whenever a new patient is identified. 23

29 1. Plan what will go into one drug box A drug box should contain the correct number of doses for the entire course of treatment. How each dose is packaged will depend on what drugs are provided by the national TB programme. You may prepare small envelopes each containing the correct combination of loose tablets for one dose of the regimen. Alternatively, the tablets may be packaged in blisters, such as 28 tablets on one card, or doses for one week on one card. In that case, you would place the correct number of blister cards in a drug box. 6 Before you can assemble a drug box, you must know: the drugs needed in what formulation the drugs are provided (the content of FDCs or other tablets) the future patient s weight (within a range) number of tablets for each dose number of doses to include. In the standard code for TB treatment regimens, the duration of each phase is stated in months. How many doses is that? The number of doses needed has been standardized as follows: One month is considered to be 4 weeks. For a daily regimen, a patient needs 28 doses per month (4 weeks x 7 days) 7. For a 3 times per week regimen, a patient needs 12 doses per month (4 weeks x 3 doses per week). Multiply either 28 or 12 by the number of months in the phase to determine the total doses required. Standard number of doses for phases of different duration For a daily regimen (one month = 28 doses): 2 months = 56 doses 3 months = 84 doses 5 months = 140 doses 6 months = 168 doses For a 3 times per week regimen (one month = 12 doses): 4 months = 48 doses 5 months = 60 doses 6 For a Category II regimen, which includes streptomycin during the first 2 months, you will not place the streptomycin in the drug box, but must put 56 doses (streptomycin vials, water for injection, sterile needles and syringes) in reserve for use with a TB patient. 7 Note that when a patient takes the anti-tb drugs 6 days per week, it will require more than 4 weeks to take 28 doses. This is acceptable; the important thing is for the patient to take all the required doses. 24

30 Complete steps a e below to plan for making a drug box, writing the numbers on a piece of paper or worksheet. An example worksheet is provided on the next page. (A blank worksheet for future use is provided on page 28 in this module and also in the Reference Booklet.) a) Refer to a table of treatment regimens (such as on page 30) and find the appropriate regimen for the category of patient. Record the category, regimen and weight at the top of the worksheet. Specify the weight range for which the box will be assembled. b) Read the code for the regimen to determine the drugs needed for the initial phase. Record the tablets that will be used for the initial phase, listing each FDC or separate tablet on a different line. Specify the formulation (content and strength) of each tablet. Specify the frequency (daily or 3 times per week). (See Annex A for a review of how to read the drug code for TB treatment regimens.) c) Read the table of treatment regimens to find out the number of each tablet per dose for the patient s weight. Record the number of tablets per dose. (See Annex C or your national TB programme s table of treatment regimens. d) Write the number of doses per month and the number of months in the phase. 28 doses is the standard number of doses per month for a daily regimen. 12 doses is the standard number of doses per month for a 3 times per week regimen. Multiply to determine the number of doses to include for the phase. e) Repeat steps b, c and d for the continuation phase. Refer to the code for the regimen to determine the frequency (daily or 3 times per week) and the duration of the phase in months. Keep the completed worksheet for reference whenever you need to assemble a drug box for this category and weight range. 25

31 EXAMPLE Worksheet for drug box assembly Category box to be made: Category I Code for regimen: 2(HRZE)/4(HR) 3 Patient s weight: kg Initial phase a) On table of treatment regimens, find regimen for category of patient and record on worksheet. Also record the weight of patient (range). b) List each tablet on a separate line and note the formulation and strength. Specify frequency. Drugs and formulation (HRZE) (H 75mg + R 150mg + Z 400 mg + E 275 mg tablet) Frequency Number of tablets per dose daily 3 Doses per month Duration in months Number of doses c) From table of treatment regimens, determine number of tablets per dose. d) Write the number of doses per month and number of months. Then multiply to calculate number of doses to include. e) Repeat steps b, c and d for the continuation phase to specify the tablets needed for each dose, and calculate the number of doses to include. Continuation phase Drugs and formulation (HR) (H 150mg + R 150mg tablet) Frequency Number of tablets per dose 3 times per week 3 Doses per month Duration in months Number of doses

32 2. Gather together quantities of tablets and preassemble envelopes or packages of tablets In some health facilities, staff prepare a number of drug boxes ahead of time for the most common treatment categories and weight of patient. In others, particularly in smaller health facilities, staff assemble a box when beginning treatment for a new TB patient, so that the box is prepared for the patient s category and weight. (Note: Do not prepare more drug boxes than the number of patients you expect next quarter to prevent problems with expired drugs in drug boxes.) However, complete as much assembly as possible ahead of time. For example, have ready a number of empty boxes, and blister packs or envelopes prepared with the usual number of tablets needed. Be familiar with the weight categories and number of tablets needed for each dose. Notice that Category I and Category II use the same daily dose of (HRZE) tablets in the initial phase, but the duration differs (2 months for Category I and 3 months for Category II.) You may preassemble packages of one month s supply (28 doses) for different weight categories, such as 3 (HRZE) tablets per dose for kg and 4 (HRZE) tablets per dose for kg. Then to assemble the initial-phase drugs for a new Category I patient who weighs 50 kg, you would just have to pick up 2 months packages of 3 tablets per dose. For a Category II patient who weighs 50 kg, you would pick up 3 months packages of 3 tablets per dose. In addition, you would place in reserve 56 doses of streptomycin (and 56 vials of sterile water, and sterile needles and syringes) for the first 2 months of Category II treatment. To gather quantities of tablets to assemble a number of drug boxes: Decide how many drug boxes you need to assemble for each category and weight range. Refer to a completed Worksheet for drug box assembly for each category (and weight range) to total the number of different tablets required per box. Multiply by the number of boxes that you want to assemble. Use this number to estimate the tablets to take out from the storeroom. (Streptomycin is not put into each drug box, but should be kept in reserve for TB patients, perhaps in a separate place from general stocks of streptomycin.) When you gather the drugs that you will use, check the expiry dates of the drugs. Use older stock first. Do not use any drugs that have expired or will expire during the treatment period. 3. Assemble a drug box Refer to a completed Worksheet for drug box assembly for the category and weight range. Assemble drugs for the initial phase Count the tablets for one dose of the initial phase. This may be one blister pack or part of a blister pack, or you may need to put strips or loose tablets for one dose into a small envelope. Then assemble the number of doses needed. If you are assembling envelopes, mark each envelope with an I (for initial phase). 27

33 Then assemble drugs for the continuation phase Count the tablets for one dose of the continuation phase. This may be one blister pack or part of a blister pack, or you may need to put strips or loose tablets for one dose into a small envelope. Then assemble the number of doses needed. If you are assembling envelopes, mark each envelope with a C. Place the envelopes into the drug box Put all the blister packs or envelopes into a bag or box, separating the drugs for two phases by putting a divider into the box. Label the box with the category and code. In the example on page 25, the label would read Category I, 2(HRZE) / 4(HR) 3. Also write the earliest expiry date of the drugs included. An alternative is to put all the doses for each phase into a separate bag, labelled with the category, phase and code. Then two bags are required for each patient. 4. Organize the drug boxes for future use Place the drug boxes in the storeroom (fully assembled or partially assembled). Keep records of: the number of new drug boxes of each category placed on the shelf partially assembled boxes, such as packages of one month s doses. Label every box or package in the storeroom and organize the boxes so that health workers can easily locate a drug box for each treatment category. When a new patient will begin treatment, the health worker will take out a new drug box, label the box with the patient s name (and District TB Number when available), and place it with the drug boxes for other current TB patients. All drug boxes for current TB patients should be kept in a convenient, safe place that is accessible to the health worker giving directly observed treatment each day. 28

34 Category box to be made: Code for regimen: Patient s weight: Initial phase Worksheet for drug box assembly Drugs and formulation Number of tablets per dose Frequency Doses per month Duration in months Number of doses Continuation phase Drugs and formulation Number of tablets per dose Frequency Doses per month Duration in months Number of envelopes 29

35 Annex C Examples of recommended TB treatment regimens (by weight and using fixed-dose combination drugs) Category I regimen Initial phase (2 months) Continuation phase (4 or 6 months) Regimen 2(HRZE) 4(HR) 3 6(HE) Patient s weight Daily 56 total doses (Isoniazid 75 mg + rifampicin 150 mg + pyrazinamide 400 mg + ethambutol 275 mg) 3 times per week 48 total doses (Isoniazid 150 mg + rifampicin 150 mg) for 4 months Daily 168 total doses (Isoniazid 150 mg + ethambutol 400 mg) for 6 months kg kg kg Over 70 kg Category II regimen Initial phase (3 months) Continuation phase ( 5 months) Regimen 2(HRZE)S / 1(HRZE) 5(HR) 3 E 3 5(HR)E Patient s weight Daily 84 total doses of HRZE plus 56 doses of S (Isoniazid 75 mg + rifampicin 150 mg + pyrazinamide 400 mg + ethambutol 275 mg) Streptomycin (vials, IM) 2 months 3 times per week 60 total doses (Isoniazid 150 mg + rifampicin 150 mg) + ethambutol 400 mg Daily 140 total doses (Isoniazid 75 mg + rifampicin 150 mg) + ethambutol 400 mg kg kg kg 4 1 g* Over 70 kg 5 1 g* * 750 mg for patients aged over 60 years Category III regimen May be same as Category I (see above) or as below (without ethambutol in initial phase) Initial phase (2 months) Continuation phase (4 or 6 months) Regimen 2(HRZ) 4(HR) 3 6(HE) Daily 56 total doses 3 times per week 48 total doses Daily 168 total doses (Isoniazid 75 mg + (Isoniazid 150 mg + (Isoniazid 150 mg + Patient s rifampicin 150 mg + rifampicin 150 mg) ethambutol 400 mg) weight pyrazinamide 400 mg) for 4 months for 6 months kg kg kg Over 70 kg

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